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Clinical Trial
. 2011 May;6(5):1049-56.
doi: 10.2215/CJN.10451110. Epub 2011 Mar 17.

Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances

Bertrand L Jaber  1 , Brigitte Schiller, John M Burkart, Rachid Daoui, Michael A Kraus, Yoojin Lee, Brent W Miller, Isaac Teitelbaum, Amy W Williams, Fredric O Finkelstein; FREEDOM Study Group
Collaborators, Affiliations
Clinical Trial

Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances

Bertrand L Jaber et al. Clin J Am Soc Nephrol. 2011 May.

Abstract

Background and objectives: Restless legs syndrome (RLS) and sleep disturbances are common among in-center hemodialysis patients and are associated with increased morbidity/mortality.

Design, setting, participants, & measurements: The FREEDOM study is an ongoing prospective cohort study investigating the benefits of home short daily hemodialysis (SDHD) (6 times/week). In this interim report, we examine the long-term effect of SDHD on the prevalence and severity of RLS, as measured by the International Restless Legs Syndrome (IRLS) Study Group rating scale, and sleep disturbances, as measured by the Medical Outcomes Study sleep survey.

Results: 235 participants were included in this report (intention-to-treat cohort), of which 127 completed the 12-month follow-up (per-protocol cohort). Mean age was 52 years, 55% had an arteriovenous fistula, and 40% suffered from RLS. In the per-protocol analysis, among patients with RLS, the mean IRLS score improved significantly at month 12, after adjustment for use of RLS-related medications (18 versus 11). Among patients with moderate-to-severe RLS (IRLS score ≥15), there was an even greater improvement in the IRLS score (23 versus 13). The intention-to-treat analysis yielded similar results. Over 12 months, there was decline in the percentage of patients reporting RLS (35% versus 26%) and those reporting moderate-to-severe RLS (59% versus 43%). There was a similar and sustained 12-month improvement in several scales of the sleep survey, after adjustment for presence of RLS and use of anxiolytics and hypnotics.

Conclusions: Home SDHD is associated with long-term improvement in the prevalence and severity of RLS and sleep disturbances.

Trial registration: ClinicalTrials.gov NCT00288613.

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Figures

Figure 1.
Figure 1.
Percentage of study participants with RLS at baseline and after 12 months of short daily hemodialysis (per-protocol cohort, n = 127). P = 0.05 by the McNemar test.
Figure 2.
Figure 2.
Percentage of study participants with moderate-to-severe restless legs symptoms (defined by IRLS score, ≥15) at baseline and after 12 months of short daily hemodialysis (per-protocol subcohort, n = 46). P = 0.06 by the McNemar test.
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